Automated Alerts for Heart Valve Issues (ALERT Trial)

N/A

Recruiting

Led By Sreekanth Vemulapalli, MD

Research Sponsored by Tempus Labs

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

1. Mitral Regurgitation

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days from a qualifying echocardiogram indicating severe aortic stenosis or mitral regurgitation

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if using automated notifications from Tempus Next can help doctors identify and evaluate patients who may need Valve Intervention (VI). They will look at how these notifications affect whether patients undergo procedures for

Who is the study for?

This trial is for patients with severe aortic stenosis (AS) or mitral regurgitation (MR), as indicated by specific measurements on an echocardiogram. It's not for those who don't meet the required echo criteria, such as AVA ≤ 1.0 cm2 or Dimensionless index ≤ 0.25 for AS, and certain criteria for MR.

What is being tested?

The study tests if automated alerts to doctors can reduce under-treatment of severe AS and MR by comparing follow-up rates and valve surgeries between two groups: one receiving alerts and one not.

What are the potential side effects?

Since this trial involves sending automated notifications rather than drugs or medical procedures, there are no direct side effects from the intervention itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have mitral regurgitation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days from a qualifying echocardiogram indicating severe aortic stenosis or mitral regurgitation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days from a qualifying echocardiogram indicating severe aortic stenosis or mitral regurgitation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days from a qualifying echocardiogram indicating severe aortic stenosis or mitral regurgitation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Establish impact of automated alerts on the hierarchical composite endpoint of valve intervention (VI) or follow-up visit with a multi-disciplinary heart team (MHT).